Devices

Viracor-IBT Distributing Unapproved Zika Tests: FDA

FDA says that Viracor-IBT Laboratories, Lee’s Summit, MO, is distributing a Zika Virus IgG test and Zika Virus IgG and IgM Panel without marketing clearance, approval, or authorization from the agency. A 10/21 untitled letter says that the agency issued an emergency use authorization for the firm’s Zika Virus Real-time RT-PCR Test, but that authorization does not extend to the emergency use of any other in vitro diagnostic tests, such as the two in question.

A review of the firm’s Web site determined that the devices are adulterated because the company does not have an approved PMA or IDE for them, the letter says. They also are misbranded because the firm did not notify FDA of its intent to introduce them into commercial distribution.

“Our review indicates that you are offering these tests that may pose significant risks to patients and the public,” the letter says. “Your Zika Virus IgG and Zika Virus IgG and IgM Panel must not be distributed and used for clinical diagnosis until they are cleared, approved, or granted marketing authorization. In light of the current Zika virus public health emergency, it is particularly important for FDA to review information related to your devices’ design, validation, and performance characteristics.”

The company was told to stop commercial distribution of the devices and to promptly notify each affected client, including patients and doctors, about the issue and provide FDA copies of the notification letters.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome